FDA Approves Revised Indication for Diabetic Macular Edema Treatment

Allergan Inc. announced today that the US Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME) in the general DME patient population.

Ozurdex was originally approved in June 2014 as a treatment for adult pseudophakic (artificial lens implant) and phakic (scheduled for cataract surgery) DME patients. Ozurdex is also indicated for the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion, and for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

The FDA revised the indication for Ozurdex after reviewing clinical data demonstrating efficacy and safety. The data came from the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) study, which included “two multi-center 3-year sham-controlled, masked, randomized clinical studies assessing the proportion of patients with 15 or more letters improvement in best-corrected visual acuity (BCVA) from baseline.”

Study results showed that Ozurdex demonstrated long-term efficacy in the treatment of DME without the need for monthly injections. The most common adverse events reported in the studies were cataracts and elevated intraocular pressure (IOP). According to Allergan, “an increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles.”

Ozurdex should not be used in patients with any infections or diseases in the eye, or surrounding eye area. It should also not be used in patients who have glaucoma or who have a posterior lens capsule that is torn or ruptured.

Patients being treated with Ozurdex should be monitored for endophthalmitis, eye inflammation, increased eye pressure, and retinal detachments.

The most common side effects reported in patients with diabetic macular edema include: cataract, increased eye pressure, conjunctival blood spot, reduced vision, inflammation of the conjunctiva, specks that float in the field of vision, swelling of the conjunctiva, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid, high blood pressure and bronchitis.

Repeated injections with Ozurdex may increase the risk of cataract. After receiving initial treatment with Ozurdex, patients may be at risk for serious eye infection or increased eye pressure, among other potential complications. Full prescribing and safety information for Ozurdex is available here.

Scott M. Whitcup, MD, Executive Vice President, Research and Development and Chief Scientific Officer, Allergan, said “Allergan is committed to developing innovative treatment options that address unmet patient needs, and retinal diseases such as DME are extremely difficult to manage. We are pleased that the updated indication supports the use of Ozurdex to help improve vision for more patients with DME.”